Validation built in, not bolted on.
Validation packages for FDA Part 820 and Part 11 are built in, not bolted on. You get the documentation you need without building it from scratch — and an audit trail that holds up under review.
What's covered
The compliance foundation, handled.
FDA 21 CFR Part 820
Quality System support is woven into the workflow — document control, device history records, and process discipline that map to your QMS.
21 CFR Part 11
Electronic records and electronic signatures with identity, intent, and timestamps captured on every signing event.
IQ / OQ / PQ packages
Installation, operational, and performance qualification documentation comes prepared, so your validation effort starts at the finish line.
Complete audit trail
Who did what, when, and to which record — captured automatically and tamper-evident. The trail holds up to a reviewer's questions.
Review-ready eDHR
Device history records are assembled as work happens, so closing and reviewing a record is fast and consistent.
Access & data integrity
Role-based access and ALCOA+ aligned data handling keep records attributable, legible, and accurate.
How validation works
From prepared package to audit-ready, in four steps.
Start from prepared documentation
You receive the validation package up front — not a blank template. The hard part is already drafted.
Map it to your process
We tailor the documentation to your specific work instructions and quality system with you.
Execute and sign
Run your qualification protocols and capture signatures electronically inside WorkStepper.
Stay audit-ready
Every record after go-live builds your evidence automatically. You're ready before the auditor asks.
How the audit trail holds up under review
Demo video placeholderWalk into your next audit prepared.
See exactly how WorkStepper documents Part 820 and Part 11 for a team your size.